Tag: statistics

Arq Gastroenterol. 2021 Jul-Sep;58(3):281-288. doi: 10.1590/S0004-2803.202100000-49.

ABSTRACT

BACKGROUND: Percutaneous endoscopic gastrostomy (PEG) is an important option for enteral nutrition for both children and adults. It is considered a safe, effective, and advantageous technique in comparison to other complementary feeding routes. It allows continuous feeding, the feeding of patients with swallowing disorders due to neurological causes or others, and the administration of non-palatable diets or medications, all with low rates of complications and mortality.

OBJECTIVE: This study aimed to evaluate the main indications and complications of PEG in pediatric patients. In addition, the impact on the nutritional status of patients undergoing PEG was also compared with weight, body mass index (BMI), and height according to references from the World Health Organization.

METHODS: This observational and retrospective study included 152 children and adolescents who underwent PEG between January/2003 and December/2018. Patients up to 18 years of age at the time of the procedure were included. Complications related to the procedure were classified as minor or major. Patients with PEG indication for nutritional supplementation were evaluated for weight gain, height, and BMI, using the Z score at the day of the procedure and six months, 1 year, and 2 years after the procedure.

RESULTS: Indications for PEG were: swallowing disorder of neurological cause (67.1%), need for nutritional supplementation (25%), swallowing disorder of mechanical origin (6.6%), and indication of gastric decompression (1.3%). Minor complications occurred in 57.8% of patients and major complications in 9.8% of patients. The traction technique corresponded to 92.1% and puncture to 7.9%. The death rate was 1.3%. Thirty-eight patients had an indication for nutritional supplementation. In these patients, there was a gradual increase in both BMI and weight, reaching statistically significant differences (P=0.0340 and P= 0.0105, respectively). These differences were more evident in chronic renal disease patients. Height did not vary significantly (P=0.543).

CONCLUSION: PEG proved to be an advantageous option as an auxiliary feeding method in pediatric patients. Dysphagia of neurological origin was the main indication followed by the need for nutritional supplementation. PEG has low frequency of major complications and mortality. This study also showed the importance of PEG in patients who need nutritional supplementation, as it enabled patients to move from undernutrition to normal weight ranges.

PMID:34705960 | DOI:10.1590/S0004-2803.202100000-49

Arq Gastroenterol. 2021 Jul-Sep;58(3):289-295. doi: 10.1590/S0004-2803.202100000-50.

ABSTRACT

BACKGROUND: A healthy diet is recommended for patients with Crohn’s disease (CD) in remission.

OBJECTIVE: To evaluate the diet quality of patients with CD.

METHODS: Cross-sectional study with patients with CD and clinical remission using the biological agent infliximab. The diet quality was assessed using the Diet Quality Index-Revised (DQI-R). DQI-R was calculated based on 24-hour dietary recalls (24HR), being classified as “inadequate diet” (≤40 points), “diet requiring modifications” (41 to 64 points) and “healthy diet” (≥65 points). Weight, height and waist circumference (WC) of patients were assessed. For comparison between groups, Student’s t-test or Mann-Whitney was used. For correlation between continuous variables, Pearson or Spearman coefficient was used. Values of P<0.05 indicated statistical significance.

RESULTS: A total of 43 patients participated in the study. The final DQI-R score was 49.1 points – “diet requiring modifications”. No patient received the classification of “healthy diet” (maximum score =59.7), 55.8% presented “diet requiring modifications” and 44.2% “inadequate diet”. When comparing the “inadequate diet” and “diet requiring modifications” groups, a lower mean age was observed in the “inadequate diet” group (37.6±14.8 versus 47.4±10.5 y, P=0.02). It was found that 44.2% of the patients were overweight (body mass index [BMI] ≥25 kg/m²) and had increased WC (women: WC ≥80 cm and men: WC ≥94 cm). A positive correlation was found between the final DQI-R score and BMI (P=0.046; r=0.346).

CONCLUSION: Patients with CD in clinical remission using infliximab are not adopting a diet considered healthy, which points to the need for an individualized nutritional approach.

PMID:34705961 | DOI:10.1590/S0004-2803.202100000-50

Arq Gastroenterol. 2021 Jul-Sep;58(3):322-328. doi: 10.1590/S0004-2803.202100000-55.

ABSTRACT

BACKGROUND: Crohn’s disease (CD) is an inflammatory bowel disease characterized by a chronic and recurrent inflammation of the gastrointestinal tract caused by an interaction of genetic and environmental factors.

OBJECTIVE: To compare the quality and acceptance of two different oral contrast volumes for computed tomography enterography in Crohn’s disease patients.

METHODS: A cross-sectional study was conducted in 58 consecutive Crohn’s disease patients who randomly received an oral contrast agent composed of 78.75 g polyethylene glycol diluted in either 1,000 mL or 2,000 mL of water. An examination was performed to evaluate the presence of inflammation or complications in the small bowel. The variables included the quality of intestinal segment filling and luminal distension, and oral contrast agent acceptance and tolerance in the patients. Statistical analysis included descriptive statistics and association tests.

RESULTS: A total of 58 patients were assessed, in which 58.6% were female, 34.5% exhibited clinically-active disease, and 63.8% were receiving biologic therapy. As for comparative analysis between the two different volumes of oral contrast, no statistically significant difference was found regarding bowel loop filling (P=0.58) and adequate luminal distension (P=0.45). Patients who received a larger volume (2,000 mL) exhibited side-effects more frequently (51.7% vs 31.0%; P=0.06) and had greater difficulty ingesting the agent (65.5% vs 37.9%; P=0.07) compared with a volume of 1,000 mL.

CONCLUSION: The quality of computed tomography enterography was not influenced by the contrast volume. However, acceptance and tolerance were better in the 1,000 mL group.

PMID:34705966 | DOI:10.1590/S0004-2803.202100000-55

Arq Gastroenterol. 2021 Jul-Sep;58(3):270-275. doi: 10.1590/S0004-2803.202100000-47.

ABSTRACT

BACKGROUND: Endoscopic retrograde cholangiopancreatography is a widely used therapeutic modality for the pancreaticobiliary tree. However, it is responsible for the highest rates of complications among the endoscopic procedures, especially post-endoscopic retrograde cholangiopancreatography pancreatitis. The preventive methods include mechanical and pharmacological approaches, such as the use of non-steroidal anti-inflammatory drugs.

OBJECTIVE: To compare the efficacy of two different strategies using non-steroidal anti-inflammatory drugs for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis, and to clarify the uncertainty about the route of administration of non-steroidal anti-inflammatory drugs in the prevention of this complication.

METHODS: This was a prospective trial. Two therapeutic groups were compared with a control group that was composed of patients who underwent endoscopic retrograde cholangiopancreatography, performed in the same service and by the same team in the period preceding the study (historical series), without the administration of any type of prophylaxis. The first group received 100 mg rectal diclofenac. The second group received 100 mg intravenous ketoprofen. Both groups were compared, separately and jointly, with the control group.

RESULTS: Post-endoscopic retrograde cholangiopancreatography pancreatitis occurred in 4.39% (12/273) of the participants. In the group without prophylaxis, the incidence was 6.89% (10/145). Among those who received intravenous ketoprofen, the incidence was 2.56% (2/78). No cases of acute post-procedural pancreatitis were observed in the group that received rectal diclofenac (0/52). Although there was no statistical difference between the therapeutic groups when they were separately analyzed, a statistical difference in the prevention of post-procedural pancreatitis was observed when they were analyzed together (P=0.037).

CONCLUSION: This study provides evidence for the efficacy of non-steroidal anti-inflammatory drugs in the prophylaxis of post-endoscopic retrograde cholangiopancreatography pancreatitis.

PMID:34705958 | DOI:10.1590/S0004-2803.202100000-47

Pain Physician. 2021 Nov;24(7):E1075-E1083.

ABSTRACT

BACKGROUND: Computed tomography (CT)-guided radiofrequency thermocoagulation of lumbar sympathetic nerve has been gradually applied to the treatment of many autonomic nerve disorders, such as plantar hyperhidrosis (PH) and diabetic peripheral neuropathy (DPN). The difference in the success rate of operation between the left and right sides is not yet studied.

OBJECTIVE: This study aimed to explore a statistically significant difference between the success rate of left and right CT-guided radiofrequency thermocoagulation of lumbar sympathetic nerve and screen the risk factors affecting the success rate of the right surgery.

STUDY DESIGN: This is a single-center retrospective cohort study.

SETTING: The study was carried out in the Pain Department of the affiliated Hospital of Jiaxing College in Jiaxing, China.

METHODS: A total of 86 patients who received CT-guided radiofrequency thermocoagulation of lumbar sympathetic nerve were included in this study approved by the Ethics Committee of the affiliated Hospital of Jiaxing University. Nonparametric and chi-square tests were used to compare the operation times, CT scan times, and success rate on the left and right sides. Binary multivariate logistic regression analysis was applied to screen the risk factors on the outcome variable.

RESULTS: The bilateral operation time, CT scan times, and success rate differed significantly between the left and right sides (P < 0.05). After univariate analysis, 6 covariates (gender, body mass index, treatment history, operation time, CT scan times, and puncture needle type) were selected. Finally, the multivariate regression model screened out 2 risk factors: the operation time and puncture needle type.

LIMITATIONS: We look forward to increasing the sample size in follow-up studies and exploring relevant conclusions in randomized controlled trials.

CONCLUSION: This study proved that in CT-guided radiofrequency thermocoagulation of the lumbar sympathetic nerve, the difficulty of operation on the right side was significantly high, and the success rate was also lower than that on the contralateral side. Multivariate logistic regression analysis showed that operation time and type of puncture needle were risk factors affecting the success rate of the operation. These findings laid a foundation for the accomplishment of technical improvement and innovation in the future. A preliminary exploration was carried out to reduce the risk and complications and to improve the success rate of the operation.

PMID:34704717

Pain Physician. 2021 Nov;24(7):E1007-E1013.

ABSTRACT

BACKGROUND: Saline or local anesthetic injection into the epidural space increases intracranial pressure (ICP), at least transiently. Measurement of the optic nerve sheath diameter (ONSD) using ocular ultrasonography is one of the noninvasive methods for ICP assessment.

OBJECTIVES: The purpose of this study is to investigate the effects of the different volume on the ONSD and cerebral oxygen saturation (rSO2) during thoracic epidural saline injection under awake conditions.

STUDY DESIGN: Prospective randomized, controlled trial.

SETTING: An interventional pain management practice in South Korea.

METHODS: This study included 71 patients receiving thoracic epidural catheterization for pain management, following upper abdominal or thoracic surgery. Following successful epidural space confirmation, patients were randomly allocated to receive 5 mL (5 mL group), 10 mL (10 mL group), and 20 mL (20 mL group) of epidural normal saline. Transorbital sonography was performed to measure the ONSD. This was measured at 3 mm posterior to the optic nerve head. An rSO2 was measured using cerebral oximeter sensors.

RESULTS: All 3 groups showed significant increases of ONSD from 10 minutes to 40 minutes as compared to baseline (before procedure). Among the 3 groups, the 20 mL group demonstrated the most significantly increased ONSD, as compared to the 5 mL and 10 mL groups. At the 20 minute and 40 minute time points, the ONSD showed a volume-dependent increase (P = 0.0005, P = 0.014). All 3 groups showed the rSO2 to be distributed between 60~70% without any statistical difference.

LIMITATIONS: We could not determine the returning point of the normalized ONSD value.

CONCLUSION: Twenty milliliters of normal saline epidural injection resulted in a significant increase of ONSD, as compared to the 5 mL and 10 mL groups. Our results also indicate that an increase of ONSD occurs in accordance with the injected volume of normal saline.

PMID:34704711

Pain Physician. 2021 Nov;24(7):E989-E996.

ABSTRACT

BACKGROUND: Intraarticular bupivacaine produces sufficient analgesia after arthroscopic knee surgery, but its analgesic duration is short. There is a need to search for an adjuvant with a longer duration of analgesia.

OBJECTIVES: This study aimed to compare the duration of analgesia, total rescue analgesic consumptions, pain intensity, adverse effects, and patient satisfaction of dexmedetomidine and fentanyl as adjuvants to intraarticular bupivacaine for analgesia after knee arthroscopy.

STUDY DESIGN: A prospective double-blind randomized controlled study.

SETTING: Zagazig University Hospitals.

METHODS: After ending arthroscopy and 15 minutes before deflation of the tourniquet, 45 patients were randomly allocated into 3 equal groups: Group B (n = 15) received an intraarticular injection of 50 mg (20 mL) bupivacaine 0.25% plus 1 mL saline; group BD (n = 15): received an intraarticular injection of 20 mL bupivacaine 0.25% plus 100 µg (1 mL) dexmedetomidine; and group BF (n = 15) received an intraarticular injection of 20 mL bupivacaine 0.25% plus 50 µg (1 mL) fentanyl.

RESULTS: The BF group had a statistically significant longest duration of analgesia (693.3 ± 22.6 minutes) compared to group the BD (505.8 ± 23.5 minutes) and group B (244.1 ± 17.5 minutes) (P < 0.0001). The total meperidine consumption was statistically significantly decreased in group BF (35 ± 12.6 mg) compared to the BD and B groups (60 ± 12.6 mg and 83.3 ± 15.4 mg respectively) (P < 0.0001). Groups BF and BD showed a highly statistically significant lower postoperative static and dynamic pain scores at 30 minutes, 1, 2, 4, and 6 hours compared to group B. However, group BF was comparable to group BD at the same time intervals. Postoperative static and dynamic pain scores showed a highly statistically significant higher values at 4 hours in group B, 8 hours in group BD, and 12 hours in group BF (P < 0.0001). No significant side effects were observed in the groups. The duration of analgesia was the most important parameter that determined patient satisfaction.

LIMITATIONS: Small sample size and lack of studies that compare both adjuvants.

CONCLUSIONS: Fifty µg of fentanyl as an adjuvant to intraarticular bupivacaine produces effective and safe analgesia after knee arthroscopy as 100 µg of dexmedetomidine and has a longer analgesia duration in the first postoperative 24 hours.

PMID:34704709

Drug Metab Pers Ther. 2020 Sep 2;35(4). doi: 10.1515/dmpt-2020-0115.

ABSTRACT

OBJECTIVES: The pharmacokinetics of moxifloxacin in plasma and saliva was investigated in this study.

METHODS: The pharmacokinetics of two specialty drugs of moxifloxacin – reference (Ref) and test (Test) preparation – was studied in 18 healthy volunteers after a single oral dose of 400 mg.

RESULTS: It was found that the concentration of moxifloxacin in saliva 3-24 h after taking the drugs was statistically significantly higher than that in plasma. A high correlation was observed between the concentration of moxifloxacin in plasma and saliva of volunteers after taking of Ref and Test. Some pharmacokinetic parameters, calculated by the concentration of moxifloxacin in saliva and plasma, are statistically different. A technique is proposed for extrapolating the concentration of moxifloxacin in plasma according to its concentration in saliva using the established linear relationship between the moxifloxacin in plasma and saliva of volunteers in time interval of 3-24 h after taking Ref. Based on the obtained extrapolated concentration of moxifloxacin, the pharmacokinetic parameters were calculated for two studied drugs and did not statistically differ from the parameters calculated according to the data in plasma.

CONCLUSIONS: The developed method of concentration extrapolation allows the use of saliva for pharmacokinetic studies of the tablet preparations of moxifloxacin.

PMID:34704694 | DOI:10.1515/dmpt-2020-0115

Chin Med J (Engl). 2021 Sep 20. doi: 10.1097/CM9.0000000000001729. Online ahead of print.

ABSTRACT

BACKGROUNDS: Previous surveys have found that children with iron deficiency (ID) were likely to suffer from early childhood caries (ECC). We aimed to assess the scientific evidence about whether ID is intrinsically related to ECC.

METHODS: The medical subject headings (MeSH) terms and free words were searched on PubMed, Web of Science, Cochrane, China National Knowledge Infrastructure, Wanfang, and the Database for Chinese Technical Periodicals from March 2020 to September 2020. Two researchers independently screened the articles. Data extraction and cross-checking were performed for the studies that met the inclusion criteria. Meta-analysis was performed using the Cochrane Collaboration’s Review Manager 5.3 software.

RESULTS: After excluding duplication and irrelevant literature, 12 case-control studies were included in the study. The meta-analysis demonstrated that children with ECC were more likely to have ID (odds ratio [OR] = 2.63, 95% confidence interval [CI]: [1.85, 3.73], P < 0.001). There was no statistically significant association found between the level of serum ferritin and ECC (weighted mean difference (WMD) = -5.80, 95% CI: [-11.97, 0.37], P = 0.07). Children with ECC were more likely to have iron-deficiency anemia (OR = 2.74, 95% CI: [2.41,3.11], P < 0.001). The hemoglobin (HGB) levels in the ECC group were significantly lower compared with that in the ECC-free group (WMD = -9.96, 95% CI: [-15.45, -4.46], P = 0.0004). The mean corpuscular volume (MCV) levels in the ECC group were significantly lower compared with that in the ECC-free group (WMD = -3.72, 95% CI: [-6.65, -0.79], P = 0.01).

CONCLUSIONS: ID was more prevalent in children with ECC, and the markers of iron status in the ECC group, such as serum ferritin, HGB, and MCV, were relatively lower than the ECC-free group.

PMID:34704699 | DOI:10.1097/CM9.0000000000001729